CLINICAL TRIALS 

Healthcare Worker Exposure Response and Outcomes (HERO) 

With funding from the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors, Vanderbilt University Medical Center is playing a key role in a national effort to establish a registry of U.S. health care workers and test whether the anti-malarial drug hydroxychloroquine (HCQ) will protect them, their patients and their families from COVID-19. The registry is recruiting tens of thousands of health care workers from across the country including doctors, nurses, respiratory therapists and paramedics, many of whom work on the frontlines of the coronavirus pandemic and are at high risk for COVID-19 infection. VUMC and Williamson Medical Center are recruitment sites and study participants randomly selected to receive HCQ or placebo for 30 days and then will be followed for two months. In addition to serving as a source of recruitment into the clinical trial, the registry will provide valuable information about the impact of COVID-19 on health care workers and their families including such issues as stress and burnout. 

READ the full article in VUMC Reporter –

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The Healthcare Worker Exposure Response & Outcomes (HERO) Registry recently launched, inviting U.S. healthcare workers to share clinical and life experiences in order to understand the perspectives and problems faced by those on the COVID-19 pandemic front lines.


ORCHID TRIAL: (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease)  

On April 2, 2020, the ORCHID trial launched with its first enrollment at Vanderbilt University Medical Center (VUMC). This trial is investigating the effectiveness and safety of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults. Hydroxychloroquine has been used for decades to treat malaria and rheumatologic conditions. In laboratory studies, hydroxychloroquine has demonstrated activity against SARS-CoV-2, the virus that causes COVID-19. This anti-viral activity combined with its immunomodulatory effects has led to great interest in hydroxychloroquine as a potential therapy for COVID-19. However, the clinical effectiveness of hydroxychloroquine in COVID-19 is unknown.  ORCHID is a randomized, placebo-controlled clinical trial that will provide high-quality data on the effectiveness and safety of hydroxychloroquine for the treatment of COVID-19.  The trial is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network, funded by the National Heart, Lung and Blood Institute (NHLBI).  This multicenter trial will be launched at up to 44 centers in the United States.  Wesley H. Self, MD, MPH, Associate Professor of Emergency Medicine at VUMC, is the principal investigator of the ORCHID trial.  Additional Vanderbilt investigators include Todd W. Rice, Matthew W. Semler, Jonathon D. Casey, Sean P. Collins, Christopher Lindsell, and Bo Stubblefield. Clinical trial identifier: NCT04332991.  

Media Contact: Craig Boerner in the VUMC communications office (craig.boerner@vumc.org

Contact: Wesley H. Self, MD, MPH, Associate Professor of Emergency Medicine, wesley.self@vumc.org 


OBSERVATIONAL STUDY 

Influenza Vaccine Effectiveness in the Critically Ill (IVY) Network 

Healthcare Workers The Influenza Vaccine Effectiveness in the Critically Ill (IVY) Network has launched a series of observational studies evaluating COVID-19. The IVY Network is a 16-site consortium of academic medication centers in the US funded by the Centers for Disease Control and Prevention (CDC) to conduct research on acute viral respiratory infections. COVID-19 research being conducted by the network includes: investigating the prevalence of and risk factors for seroconversion among frontline healthcare workers; evaluating the risk of clinical deterioration in the weeks following a positive SARS-CoV-2 test; characterizing COVID-associated cardiomyopathy; detailing the clinical epidemiology of COVID-associated critical illness; and proving real-time surveillance data to CDC.  The IVY Network collaborates closely with CDC and is led by Vanderbilt University Medical Center (VUMC), which serves at the Clinical Coordinating Center, Data Coordinating Center, and single IRB.  Wesley H. Self, MD, MPH, Associate Professor of Emergency Medicine, is the principal investigator of the IVY Network. Additional Vanderbilt investigators include H. Keipp Talbot, Todd W. Rice, Christopher J. Lindsell, Carlos G. Grijalva, Natasha Halasa, Sean P. Collins, Adrienne Baughman, and Bo Stubblefield.      

Wesley H. Self, MD, MPH, Associate Professor of Emergency Medicine, wesley.self@vumc.org 


BIG DATA

STAR Clinical Research Network and PCORnet COVID-19 Common Data Model

The Stakeholders, Technology, and Research (STAR) CRN, led by Dr. Russell Rothman as the STAR CRN Lead PI, is launching a coordinated COVID-19 Common Data Model (CDM) at participating STAR CRN sites, in conjunction with the CDC and other PCORnet sites nationally. Funded by PCORI and the People Centered Research Foundation and designed to provide support for patient-centered outcomes research (PCORnet), the STAR CRN includes (1) Vanderbilt University Medical Center (2) the Vanderbilt Healthcare Affiliated Network (3) Meharry Medical College, (4) UNC Health Care System, (5) Duke Health Care System, (6) Health Sciences of South Carolina, (7) Wake Forest Health Care, and (8) Mayo Clinic. These systems comprise scores of academic and community hospitals, hundreds of practices and over 12 million patients nationally. In partnership with 8 additional Clinical Research Networks (CRNs), PCORnet engages with over 60 health systems and reaches over 90 million patients throughout the U.S. The purpose of the COVID-19 CDM is to characterize a cohort of COVID-19 patients nationally and provide detailed information on the demographics and pre-existing conditions for members of the CDC COVID-19 Task Force. The COVID-19 CDM will include patients testing positive for COVID-19 or with a coronavirus-related ICD 10 code.  Queries will be issued weekly by the PCORnet Coordinating Center (DCRI) to ensure updated and ongoing reports to the CDC COVID-19 Task Force.

For more information, contact Megan Cook, MHA, Director of Operations/Sr. Project Manager, STAR CRN.